A Study of Lerociclib in Participants With Advanced Breast Cancer

NCT05085002 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: EQ132-201
• Study Type: interventional
• Target: 100
• Locations: 6 countries
• Sites: 21

Brief Summary

This is a multicenter, single-arm, open-label study to evaluate the safety and efficacy of lerociclib in combination with standard endocrine therapy in female or male participants with HR+/HER2- MBC. The study population will consist of either newly diagnosed, treatment naïve participants with HR+/HER2- MBC (1L population) and participants with HR+/HER2- MBC who have already progressed on first line endocrine therapy such as tamoxifen, anastrozole, or letrozole (2L population). All premenopausal or perimenopausal female participants, and all male participants, must be receiving goserelin for at least 28 days prior to entering the study and will remain on goserelin throughout the study, in accordance with the prescribing information and according to the study site's standard practice.

Conditions

Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of AEs and SAEs

  The number and percentage of participants experiencing any TEAE and serious TEAE will be tabulated by line of therapy.

  Up to 4.5 years

Study Arms (1)

Lerociclib + letrozole or fulvestrant

OTHER

Drug: Lerociclib + Letrozole or Fulvestrant

Interventions

Lerociclib + Letrozole or Fulvestrant DRUG

All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.

Lerociclib + letrozole or fulvestrant

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be 18 or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.
• Histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer.
• Advanced (locoregionally recurrent not amenable to curative therapy, eg, surgery and/or radiotherapy, or metastatic) breast cancer
• Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
• Adequate bone marrow and organ function
• Female that is not pregnant and agrees to contraceptive use that is consistent with local regulations regarding the methods of contraception to be used during the study
• Males agree to use a highly effective method of contraception and will refrain from donating sperm from the first dose of any study intervention
• Participant is capable of giving signed informed consent

You may not qualify if:

• Symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy per the Investigator's best judgment.
• Peritoneal carcinomatosis.
• Inflammatory breast cancer at screening.
• Participant with central nervous system (CNS) involvement unless they are at least 4 weeks from prior therapy completion to starting the study treatment and have stable CNS tumor at the time of screening and not receiving steroids and/or enzyme inducing anti-epileptic medications for brain metastases.
• Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
• Has a history of prolonged QT syndrome or Torsades de Pointes
• Has received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy) or any CDK4/6 inhibitor.
• Has received prior treatment with fulvestrant.
• Use of systemic estrogens
• Participant is currently receiving any of the following substances and cannot be discontinued 14 days prior to start the treatment:
• Known strong or moderate CYP3A inducers or strong inhibition of CYP3A
• Substances that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
• Echocardiogram done within the past 12 months with ejection fraction of ≤ 45% or documented history of congestive heart failure with reduced ejection fraction.
• Evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or oral temperature \> 38°C at screening
• Interstitial pneumonia or severe impairment of lung function

Sponsors & Collaborators

• EQRx, Inc.: lead

Study Sites (21)

Cancer Specialists of North Florida

Jacksonville, Florida, 32256, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

Oregon Oncology Specialists

Salem, Oregon, 97301, United States

Location

Cancer Care Associates of York, Inc.

York, Pennsylvania, 17403, United States

Location

Tranquil Clinical Research

Webster, Texas, 16969, United States

Location

Northwest Medical Specialties PLLC

Tacoma, Washington, 98405, United States

Location

UZA

Edegem, 2650, Belgium

Location

Ziekenhuizen K.U.Leuven, Campus gasthuisberg

Leuven, 3000, Belgium

Location

CHA Libramont

Libramont, 6800, Belgium

Location

Clinique Saint-Pierre asbl

Ottignies, 1340, Belgium

Location

vzw Verenigde Ziekenhuizen van Waas en Durme - VITAZ

Sint-Niklaas, 9100, Belgium

Location

LTD "Brothers"

Batumi, 6010, Georgia

Location

ARENSIA Exploratory Medicine LLC

Tbilisi, 0112, Georgia

Location

Ltd Israeli-Georgian Medical Research Clinic Helsicore

Tbilisi, 0112, Georgia

Location

LTD "Health House"

Tbilisi, 0144, Georgia

Location

Ltd "Multiprofile Clinic Consilium Medulla "

Tbilisi, 0186, Georgia

Location

Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"

Meldola, 47014, Italy

Location

PanAmerican Clinical Research Guadalajara

Guadalajara, Jalisco, 44670, Mexico

Location

PanAmerican Clinical Research Cuernavaca

Cuernavaca, 66290, Mexico

Location

PanAmerican Clinical Research, Queretaro

Querétaro, 76100, Mexico

Location

IMSP Institutul Oncologic, Arsenia Exploratory Medicine

Chisinau, MD-2025, Moldova

Location

MeSH Terms

Interventions

Letrozole; Fulvestrant

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: October 20, 2021
• Study Start: December 21, 2021
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: March 12, 2024

Record last verified: 2023-12

Locations

US (6); GE (5); BE (5); IT (1); ME (3); MO (1)